4729-17-01 Definitions; institutional facility.

As used in Chapter 4729-17 of the Administrative Code:

(A) "Institutional facility" means a hospital as defined in section 3727.01 of the Revised Code, or a facility licensed by the Ohio state board of pharmacy and the Ohio department of health, the Ohio department of rehabilitation and correction, the Ohio department of developmental disabilities, or the Ohio department of mental health and addiction services at which medical care is provided on site and a medical record documenting episodes of care, including medications ordered and administered, is maintained, including but not limited to:

(1) Convalescent homes;

(2) Developmental facilities;

(3) Long term care facilities;

(4) Nursing homes;

(5) Psychiatric facilities;

(6) Rehabilitation facilities;

(7) Developmental disability facilities;

(8) Level III sub-acute detoxification facilities.

(B) "Inpatient" means any person who receives drugs for use while within the institutional facility.

(C) "Inpatient prescription" means a written, electronic, or oral order for a drug to be dispensed for use in treating an inpatient.

(D) "Dispensing of a drug pursuant to an inpatient prescription" means the professional review by a pharmacist required to place a specific drug in final association with the name of a particular inpatient pursuant to the lawful order of a prescriber. In the case of an automated drug delivery system meeting the requirements of rule 4729-5-35 of the Administrative Code, the final association with the name of a particular inpatient will be deemed to have occurred when the pharmacist has given final approval to the patient specific order in the system.

(E) "Contingency drugs" are those drugs which may be required to meet the therapeutic needs of inpatients when a licensed pharmacist is not available and personally in full and actual charge of the institutional pharmacy.

(F) "Emergency drugs" are those drugs which are required to meet the immediate therapeutic needs of inpatients in order to sustain life in an emergency crisis.

(G) "Outpatient" means any person who receives drugs for use outside of the institutional facility.

(H) "Electronic drug record keeping system" means a system of storing drug records electronically and capturing the positive identification of the person responsible for a specific drug transaction including, but not limited to, the prescribing, administering, or dispensing of a drug.

(I) "Positive identification" has the same meaning as paragraph (N) of rule 4729-5-01 of the Administrative Code except that a specific hospital having a closed electronic drug record keeping system may be permitted to use identifiers utilizing both a password combined with a personal identifier to document the positive identification of each user for, but not limited to, the prescribing and administration of a drug if approved by the board of pharmacy.

(1) At a minimum, the following items will be considered during the approval process:

(a) Adequate audit controls are in place to detect and deter drug diversion;

(b) Adequate access controls are in place to ensure the identity of a user and to assign accountability of the user for any drug transaction;

(c) Adequate safeguards are in place to prevent and detect the unauthorized use of an individual's password and personal identifier;

(d) An ongoing quality assurance program is in place to ensure that paragraphs (I)(1)(a) to (I)(1)(c) of this rule are being fulfilled and reviewed; and

(e) Appropriate policies and procedures are in place to address all of the items in paragraphs (I)(1)(a) to (I)(1)(d) of this rule.

(2) Positive identification pursuant to paragraph (N) of rule 4729-5-01 of the Administrative Code shall always be used to document the:

(a) Dispensing, compounding, or repackaging of a drug;

(b) Removal and possession of a controlled substance to administer to a patient;

(c) Waste of a controlled substance.

(J) "Password" means a private identification that is created by a user to obtain access to an electronic drug record keeping system.

(K) "Personal identifier" means a unique user name or number for identifying and tracking a specific user's access to an electronic drug record keeping system such as social security number, user identification number, or employee number.

Effective: 4/28/2016
Five Year Review (FYR) Dates: 01/21/2016 and 12/01/2020
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.01, 4729.01
Prior Effective Dates: 9/10/76, 9/1/85, 7/1/91, 3/13/95, 1/10/96, 3/1/99, 2/1/05, 1/1/06, 4/27/07, 01/01/2011